DGM/GM - Delivery Leader - Medical Devices

Our Client is a highly visible name and a fast-growing organization in the Engineering Services Space. They have rapidly established a strong customer spread across Aerospace, Defense, Auto, Heavy Engineering and now in Medical Device sectors.

Having tasted initial success in the Medical Devices Business, we are looking for a Delivery Leader (at a Deputy General Manager / General Manager Level). Emphasis would be on New Product Development, Solutioning and Medical Regulatory.

Work Location: Hyderabad

Value Proposition: Build the Medical Devices Business and Own this with a P&L Responsibility.

Though Delivery would be the key, other major roles and responsibilities would be

- Responsible for all Medical Device department operations including revenue targets and responding to RFIs and RFPs.

- Conceptualize Proof-of-Concepts and obtain ISO13485 certification. Product Prototyping, Pilot Assembly and Design Transfer to Production.

- Ownership for the complete product development. Defining service offering, pulling the team and labs together and delivering to customer requirements.

- Hire, mentor and lead a competent cross functional engineering team with strong medical device domain expertise.

- Build strong competency in Quality Assurance and Regulatory Affairs consulting. Compilation of product Technical File, DHF, DMR for regulatory submissions.

- Adhering to Quality Management System and product development process as per ISO13485 requirements.

- Provide technical guidance and Program Manage all medical device design and engineering projects and successfully deliver on time, within budget. By professionally managing customer scope and program risks with effective project planning, monitoring & delivery and decision making. Continuous monitoring of project progress/milestones and review with top management.

- Build solutions leveraging innovative technologies to address medical device pain points for target markets: Initially USA, India and later Europe.

- Interact with and develop eco-system partners: Regulatory, Hospitals, Doctors, Medical Industry Experts panel.

We are looking for a candidate whose profile would be as under

- Engineer in Biomedical Engineering / Mechanical / Electrical & Electronics Engg. With around 15 years of hands-on experience in Design and Embedded Software

- At-least 8 to 10 years in Designing Medical Devices

- Strong Medical Device Domain expertise and in-depth understanding of the opportunities in this outsourcing market.

- Project experience in Medical Device domains providing engineering services and solutions. Leveraging cross-functional team which include Mechanical Engineering, Embedded Software, Hardware Development and/or Electrical Engineering. With strong competency either in mechanical or embedded functional areas.

- Demonstrable understanding of ISO standards ISO13485, ISO14971, Medical Devices regulations FDA 510(k), Medical safety standard IEC 60601 and comply with them.

- Went through an FDA approval cycle and ISO13485 certification would be a plus.

- Should be experienced in Medical Device New product development and regulatory affairs.

- Ability to address field failure and end-customer usage issues with corrective actions.

- Strong Medical Devices domain competency in at least two of the following areas: Diabetes, Cardiovascular, Remote Monitoring, Therapeutic, Radiology, Hospital equipment, Bed Side equipment or Orthopedics.

Please feel free to call me (Balasubramaniam or Bala) on +917899356444 for any further queries. This is only for those in the field of Medical Devices.